The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

The primary endpoint is change in A1c from baseline compared to placebo. [ Time Frame: 28 weeks ]

Original Primary Outcome Measures ICMJE (submitted: April 8, 2008)

The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

The secondary objectives of the study are to evaluate the difference between exenatide and placebo with respect to glycemic, weight, and safety assessments. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Proportion of patient achieving an HbA1c at endpoint of <7%, ≤6.5%, and <6.5 %. [ Time Frame: 28 weeks ]

The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

Body weight [ Time Frame: 28 weeks ]

The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

Fasting serum glucose [ Time Frame: 28 weeks ]

The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

Self-monitored blood glucose [ Time Frame: 28 weeks ]

The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

Fasting serum insulin concentrations [ Time Frame: 28 weeks ]

The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Official Title ICMJE

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.

Brief Summary

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

195

Estimated Completion Date

May 2020

Estimated Primary Completion Date

August 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:

are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm

have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria

have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit

have fasting C-peptide >0.6 ng/mL

have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history

fasting blood glucose 126 mg/dL (7.0 mmol/L)

random blood glucose 200 mg/dL (11.1 mmol/L)

two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:

have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide

are unwilling or unable to inject the study medication

currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily

have used oral steroids within the last 60 days or more than 20 days use within the past year

have used any weight loss medication(s) within 30 days of screening

have used insulin for more than 10 weeks during the 3 months prior to screening